New Data Show Superiority of Abbott's TriClip Device Compared to Medical Therapy for Tricuspid Regurgitation

  • Late-breaking data presented at American College of Cardiology Scientific Sessions (ACC.23) and simultaneously published in The New England Journal of Medicine demonstrate TriClip was superior to medical therapy with significant improvements in quality of life and tricuspid regurgitation (TR)
  • Findings show TriClip, an investigational device in the U.S. to treat a leaky tricuspid valve, demonstrated safety and met the primary endpoint

Abbott (NYSE: ABT) today announced late-breaking data for the TriClip™ transcatheter edge-to-edge repair (TEER) system, a first-of-its-kind minimally invasive device designed specifically for tricuspid heart valve repair. The TRILUMINATE™ Pivotal study evaluates the superiority of TriClip compared to medical therapy in treating patients with severe, symptomatic tricuspid regurgitation (TR) who are at intermediate or greater risk for open-heart surgery.

The results were presented at the American College of Cardiology's 72 nd Annual Scientific Session together with World Congress of Cardiology (ACC.23/WCC) held in New Orleans ( March 4-6, 2023 ). These data were simultaneously published in The New England Journal of Medicine   .

Key Findings From the TRILUMINATE Pivotal Study
The trial met its composite primary endpoint demonstrating superiority of the TriClip system compared to the control group (win ratio 1.48, p=0.02), primarily driven by improvement in quality of life. Mortality or tricuspid valve surgery and heart failure hospitalizations did not appear different between the groups at one year. Other positive findings include:

  • Significant reduction in TR grade. Significant reduction in TR to moderate or less (grade 2) was achieved in 87% of patients with the device at 30 days vs. 4.8% in the control group, with TR reduction sustained and durable at one year.
  • Significant improvement in quality of life. 50% of patients who received the device achieved at least a 15-point improvement in the Kansas City Cardiomyopathy Questionnaire (KCCQ) score (a self-assessment of social abilities, symptoms and quality of life) at one year vs. 26% in the control group.
  • A strong safety profile. At 30 days, only 1.7% of patients who received the device experienced major adverse events, with no urgent surgery or endocarditis. There were no occurrences of device embolization or device thrombus.

"These TRILUMINATE Pivotal trial results are promising because there have historically been very few treatment options for tricuspid regurgitation, and patients with this condition are often not eligible for open-heart surgery due to multiple co-morbidities or other factors," said Paul Sorajja , M.D., the Roger L. and Lynn C. Headrick Family Chair of the Valve Science Center for the Minneapolis Heart Institute Foundation and director of the Center for Valve and Structural Heart Disease for the Minneapolis Heart Institute at Abbott Northwestern Hospital. "The trial data and real-world use in Europe from the bRIGHT post-approval study show TriClip's ability to safely and effectively repair the tricuspid valve in patients and improve their quality of life."

"These TRILUMINATE Pivotal data show TriClip is the first minimally invasive device therapy for the treatment of tricuspid regurgitation to provide durable improvements in TR severity and quality of life that go beyond taking medication to manage symptoms," said Michael Dale , senior vice president of Abbott's structural heart business. "When left unaddressed, TR can be debilitating and life-threatening. By repairing the damage caused by structural heart disease, TriClip G4 and our latest technological innovations are helping people reclaim their lives so they can get back to doing what they love."

Abbott will also be presenting at ACC late-breaking five-year results from its landmark COAPT™ trial of the MitraClip™ TEER device for functional mitral regurgitation in heart failure.

About the Abbott TRILUMINATE Pivotal Trial
The TRILUMINATE Pivotal trial is the first randomized, controlled clinical study to evaluate the safety and effectiveness of transcatheter repair with the TriClip system compared to medical therapy in people with severe TR.

The primary endpoint was a composite of all-cause mortality or tricuspid valve surgery, heart failure hospitalizations, and quality-of-life improvement measured by the KCCQ score.

For U.S. important safety information on MitraClip, visit https://abbo.tt/MitraClipG4ISI .

TriClip is approved for use in more than 50 countries, including in Europe and Canada, and is an investigational device in the U.S.

About Abbott:
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 115,000 colleagues serve people in more than 160 countries.

Connect with us at www.abbott.com , on LinkedIn at www.linkedin.com/company/abbott-/ , on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews.

Cision View original content: https://www.prnewswire.com/news-releases/new-data-show-superiority-of-abbotts-triclip-device-compared-to-medical-therapy-for-tricuspid-regurgitation-301762749.html

SOURCE Abbott

News Provided by PR Newswire via QuoteMedia

ABT
The Conversation (0)
Abbott Announces New Partnerships and Programs to Advance its Diversity in Clinical Trials Initiative

Abbott Announces New Partnerships and Programs to Advance its Diversity in Clinical Trials Initiative

  • New efforts focus on research infrastructure, continued training of diverse clinical research personnel and improved diversity within Abbott's own clinical trials
  • Abbott's Diversity in Clinical Trials initiative aligns with the company's continued focus for greater health equity, expanded access, affordability and removing barriers to life-saving technology and innovation
  • The new programs build on a successful first year of the multi-million-dollar corporate initiative

Abbott (NYSE: ABT) today announced a series of new programs within its multi-million-dollar initiative to increase diversity in clinical trials and improve care among under-represented populations. The new additions to Abbott's Diversity in Clinical Trials initiative build on the partnerships, scholarships, and the focus on diversified participants in the company's own clinical trials during the initiative's first year.

The latest programs include the launch of a new initiative with the Norton Healthcare Foundation to build and implement new models of sustainable clinical research alongside the Institute for Health Equity, a Part of Norton Healthcare in Louisville, Ky. ; a new training program for clinical research coordinators in partnership with Barnett International; and a newly-created Diversity in Research Office at Abbott focused on ensuring diverse representation in clinical trials.

News Provided by PR Newswire via QuoteMedia

Keep reading...Show less
richard murray md

Avisa Diagnostics Appoints Dr. Richard Murray as Chief Medical Officer

Avisa Diagnostics Inc. (CSE:AVBT) (Avisa), a clinical-stage medical device company developing an ultra-rapid, point-of-care biomarker breath test for the detection and monitoring of virulent bacterial lung infections, is pleased to announce that the Company has hired Richard K. Murray, M.D., to the newly created position of Chief Medical Officer (CMO).

Dr. Murray has over 25 years of industry experience. He worked at Merck & Co. for many years in positions of increasing responsibility, in a variety of business, medical and scientific areas. His most recent position was Vice President and Deputy Chief Patient Officer. Dr. Murray was also a Fellow at the Advanced Leadership Initiative at Harvard University. He has managed all areas of medical affairs, including outcomes research, medical information, professional and academic affairs, field-based medical physicians, and investigator-initiated trials globally. Prior to his industry career, he was a practicing physician in cardiovascular-pulmonary medicine and an asthma researcher at the Hospital of the University of Pennsylvania. Dr. Murray has an M.D. from Howard University and an M.A. in Chemistry and A.B. in Psychology from Clark University. Dr. Murray currently is Board Chair of the Asthma and Allergy Foundation of America.

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less
Medtronic Evolut TAVR system shows durable clinical outcomes and outstanding valve performance at five years in low-risk aortic stenosis patients

Medtronic Evolut TAVR system shows durable clinical outcomes and outstanding valve performance at five years in low-risk aortic stenosis patients

Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced late-breaking data on five-year outcomes from the Evolut Low Risk Trial. Data shows, versus surgery, the Evolut™ transcatheter aortic valve replacement (TAVR) system delivers a numerically lower rate of all-cause mortality or disabling stroke at five years, strong valve performance and durable clinical outcomes. The findings were presented as late-breaking clinical science at the American College of Cardiology's Annual Scientific Session & Expo and simultaneously published in the JACC, the flagship journal of the American College of Cardiology .

The Evolut Low Risk Trial was a randomized, multicenter, international study assessing the safety and efficacy of the Evolut TAVR system versus surgery in low-risk patients. These patients had a predicted 30-day mortality risk

News Provided by PR Newswire via QuoteMedia

Keep reading...Show less
illustration of brain and cell phone.

BlinkLab Completes First Patient Test for US Autism Diagnostic Study

Digital healthcare company BlinkLab (ASX:BB1) has tested the first patient in its US autism diagnostic study, which is geared at validating the company's Dx1 test as a diagnostic aid for clinicians.

BlinkLab states in its Wednesday (March 12) release that the study is the largest digital diagnostic trial for autism in the US, with its aim being to support the early detection of developmental conditions like autism.

The first patient test took place at PriMED Clinical Research in Dayton, Ohio. PriMED, a division of PriMED Physicians, is one of two clinical sites selected for the study’s initial phase, which is targeting 100 patients.

Keep reading...Show less
Artificial Intelligence Influence on Healthcare Industry Reaching All Time Highs for Diagnostics and Treatments

Artificial Intelligence Influence on Healthcare Industry Reaching All Time Highs for Diagnostics and Treatments

FN Media Group News Commentary - A report from Fortune Business Insights said that the global artificial intelligence in healthcare market size is projected to grow from USD 27.69 billion in 2024 to USD 490.96 billion by 2032, exhibiting a CAGR of 43.2% during the forecast period. The report added: "AI in healthcare market in the U.S. is experiencing rapid expansion, driven by the increasing adoption of AI-powered solutions for diagnostics, personalized treatment, and administrative automation. North America dominated the AI in the healthcare market with a market share of 44.93% in 2023. Artificial Intelligence in healthcare is used to analyze the medical data that helps doctors and medical providers deliver accurate diagnoses and treatments to their patients. AI in healthcare assists doctors, nurses, and other healthcare workers to enhance their productivity. This advancement helps patients in treatment and improves their quality of life. Also, according to an article published by GE Healthcare, it is found that healthcare professionals are already using AI to improve data analysis, which has enabled them to diagnose their patients in a better way with proper predictions for the treatment and decrease the time spent by the medical staff on administrative functioning." Active companies active in the healthcare markets include: Avant Technologies Inc. (OTCQB: AVAI), Tempus AI, Inc. (NASDAQ: TEM), Teladoc Health (NYSE: TDOC), Aclarion, Inc. (NASDAQ: ACON), Medtronic plc (NYSE:MDT).

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less

Trian Comments on Solventum's Sale of its Purification & Filtration Business

Trian Fund Management, L.P. ("Trian"), which beneficially owns ~5% of Solventum Corporation (NYSE: SOLV) ("Solventum" or the "Company") and is the Company's largest active shareholder, commented on Solventum's recently announced sale of its Purification & Filtration business to Thermo Fisher Scientific Inc (NYSE: TMO) ("Thermo Fisher"). Trian issued the following statement:

"Trian commends Solventum on the announced sale of its Purification & Filtration business and believes this is an important first step in the Company's value creation journey. We believe that part of what attracted strategic interest at such a high valuation multiple was the division's differentiated technology and material science – attributes inherited from 3M which are present at Solventum's remaining businesses, and which we believe remain underappreciated by the market today.

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less

Trian Comments on Solventum's Sale of its Purification & Filtration Business

Trian Fund Management, L.P. ("Trian"), which beneficially owns ~5% of Solventum Corporation (NYSE: SOLV) ("Solventum" or the "Company") and is the Company's largest active shareholder, commented on Solventum's recently announced sale of its Purification & Filtration business to Thermo Fisher Scientific Inc (NYSE: TMO) ("Thermo Fisher"). Trian issued the following statement:

"Trian commends Solventum on the announced sale of its Purification & Filtration business and believes this is an important first step in the Company's value creation journey. We believe that part of what attracted strategic interest at such a high valuation multiple was the division's differentiated technology and material science – attributes inherited from 3M which are present at Solventum's remaining businesses, and which we believe remain underappreciated by the market today.

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less

Solventum Announces Sale of its Purification & Filtration Business to Thermo Fisher Scientific Inc. for $4.1B

  • Accelerates Solventum's business transformation and sharpens focus on strategic areas for growth to deliver long-term shareholder value

  • Strengthens balance sheet with proceeds to be used primarily for debt paydown

Solventum (NYSE: SOLV) today announced it has entered into a definitive agreement to sell its Purification & Filtration 1 business to Thermo Fisher Scientific Inc. (NYSE: TMO) (" Thermo Fisher ") for $4.1 billion . Solventum expects the transaction to be neutral to 2025 EPS and expects an estimated $3.4 billion in net proceeds, which it intends to use primarily to pay down debt. The transaction is expected to be completed by the end of 2025, subject to regulatory approval and customary closing conditions.

Solventum Logo (PRNewsfoto/3M Healthcare US Opco LLC)

"The sale of the Purification & Filtration business is part of phase three of our transformation plan and follows a thorough analysis of the value and strategic alignment of our businesses," said Bryan Hanson , Solventum CEO. "This transaction will enhance our strategic focus and key metrics while reducing leverage and significantly strengthening our balance sheet. It also enables us to invest in the innovation, programs and talent we need to execute our mission and deliver shareholder value."

Mr. Hanson continued, "Solventum is committed to ensuring a smooth transition for employees, customers and other stakeholders, and we are confident that Thermo Fisher will provide the Purification & Filtration business – which offers filters and membranes for use in the manufacturing of biopharmaceutical and medical technologies, microelectronics and food, beverage products and drinking water – the strategic investment and resources needed for sustaining growth and delivering customer solutions."

Solventum will discuss the transaction on its upcoming fourth quarter and full-year 2024 earnings call scheduled for February 27, 2025 . With this significant change in the Company's portfolio and the other major actions taken since becoming an independent publicly traded company on April 1, 2024 , Solventum has scheduled an Investor Day on March 20, 2025 , to provide investors with an update on the progress made, its go-forward positioning and long-range plan. The Investor Day will be held in New York City , and the Company will share additional logistical details in due course.

Morgan Stanley & Co. LLC, Perella Weinberg Partners and J.P. Morgan Securities LLC served as financial advisors to Solventum, and Cleary Gottlieb Steen & Hamilton served as legal advisor to Solventum.

1 Other than for its operations in Belgium , France and Ireland , for which Thermo Fisher granted a binding offer to Solventum

About Solventum  
At Solventum, we enable better, smarter, safer healthcare to improve lives. As a new company with a long legacy of creating breakthrough solutions for our customers' toughest challenges, we pioneer game-changing innovations at the intersection of health, material and data science that change patients' lives for the better — while empowering healthcare professionals to perform at their best. See how at Solventum.com .

Forward-Looking Statements
This news release contains forward-looking information about Solventum's financial results, estimates, and business prospects that involve substantial risks and uncertainties. In particular, statements regarding the future performance of Solventum, including guidance for 2024, are forward-looking statements. You can identify these statements by the use of words such as "anticipates," "believes," "could," "estimates," "expects," "forecasts," "goal," "guidance," "intends," "may," "outlook," "plans," "projects," "seeks," "sees," "should," "targets," "will," "would," and other words and terms of similar meaning in connection with any discussion of future operating or financial performance or business plans or prospects. Among the factors that could cause actual results to differ materially are the following: (1) the effects of, and changes in, worldwide economic, political, regulatory, international, trade and geopolitical conditions, natural disasters, war, public health crises, and other events beyond Solventum's control; (2) operational execution risks; (3) damage to our reputation or our brands; (4) risks from acquisitions, strategic alliances, divestitures and other strategic events; (5) Solventum's business dealings involving third-party partners in various markets; (6) Solventum's ability to access the capital and credit markets and changes in Solventum's credit ratings; (7) exposure to interest rate and currency risks; (8) the highly competitive environment in which Solventum operates and consolidation in the healthcare industry; (9) reduction in customers' research budgets or government funding; (10) the timing and market acceptance of Solventum's new product and service offerings; (11) ongoing working relationships with certain key healthcare professionals; (12) changes in reimbursement practices of governments or private payers or other cost containment measures; (13) Solventum's ability to obtain components or raw materials supplied by third parties and other manufacturing and related supply chain difficulties, interruptions, and disruptive factors; (14) legal and regulatory proceedings and legal compliance risks (including third-party risks) with regards to antitrust, Foreign Corrupt Practices Act (FCPA) and other anti-bribery laws, environmental laws, anti-kickback and false claims laws, privacy laws, tax laws, and other laws and regulations in the United States and other countries in which Solventum operates; (15) potential liabilities related to a broad group of perfluoroalkyl and polyfluoroalkyl substances, collectively known as "PFAS"; (16) risks related to the highly regulated environment in which Solventum operates; (17) risks associated with product liability claims; (18) climate change and measures to address climate change; (19) security breaches and other disruptions to information technology infrastructure; (20) Solventum's failure to obtain, maintain, protect, or effectively enforce its intellectual property ("IP") rights; (21) pension and postretirement obligation liabilities; (22) any failure by the 3M Company (" 3M ") to perform any of its obligations under the various separation agreements in connection with the separation from 3M (the "Spin-Off"); (23) any failure to realize the expected benefits of the Spin-Off, and/or that the Spin-Off will not be completed within the expected time frame, on the expected terms or at all; (24) a determination by the IRS or other tax authorities that the distribution or certain related transactions should be treated as taxable transactions; (25) expected financing transactions undertaken in connection with the separation and risks associated with additional indebtedness; (26) the risk that incremental costs of operating on a standalone basis (including the loss of synergies), costs of restructuring transactions and other costs incurred in connection with the separation will exceed Solventum's estimates; and (27) the impact of the Spin-Off on its businesses and the risk that the Spin-Off may be more difficult, time-consuming or costly than expected, including the impact on its resources, systems, procedures and controls, diversion of management's attention and the impact on relationships with customers, suppliers, employees and other business counterparties.

Changes in such assumptions or factors could produce significantly different results. A further description of these factors is located under "Cautionary Note Regarding Forward-Looking Statements" and "Risk Factors" in Solventum's periodic reports on file with the U.S. Securities & Exchange Commission. Solventum assumes no obligation to update any forward-looking statements discussed herein as a result of new information or future events or developments.

Cision View original content to download multimedia: https://www.prnewswire.com/news-releases/solventum-announces-sale-of-its-purification--filtration-business-to-thermo-fisher-scientific-inc-for-4-1b-302384734.html

SOURCE Solventum

News Provided by PR Newswire via QuoteMedia

Keep reading...Show less

Latest Press Releases

Related News

×